Regulatory Affairs Specialist, Medical Device, remote
| Posting date: | 27 August 2025 |
|---|---|
| Salary: | £35.0 to £45.0 per hour |
| Additional salary information: | £35 - £45 per hour umbrella |
| Hours: | Full time |
| Closing date: | 26 September 2025 |
| Location: | Manchester, Greater Manchester, ec2v 6db |
| Remote working: | Fully remote |
| Company: | Hays Specialist Recruitment |
| Job type: | Contract |
| Job reference: | 4718934_1756299170 |
Summary
Regulatory Affairs Specialist - Medical Devices, fully remote working, contract job
Your new company
Our client, a leading player in the medical device sector, is seeking a proactive and detail-oriented Regulatory Affairs Specialist to join their MBD Regulatory Affairs team. Microbiology Division of the Speciality Diagnostics GroupThis is a 5-month contract job which is fully remote
Your new role
In this pivotal role, you'll support the full product lifecycle, ensuring regulatory compliance across global markets. You'll collaborate with cross-functional teams including Market Access, Commercial, Operations, R&D, QA, and Product Management, as well as engage with regulatory agencies and regional teams.Key Responsibilities:
- Maintain and review regulatory submissions, technical files, and product labelling.
- Assess operational change requests and their impact on licences.
- Respond to customer and commercial enquiries on product classification and regulatory status.
- Support pre- and post-market licence applications across global territories.
- Assist in audit readiness and regulatory planning.
- Stay up to date with global IVD regulations and market intelligence.
What you'll need to succeed
What We're Looking For:
- Strong communication skills and attention to detail.
- Proven experience in regulatory affairs within medical devices or IVD.
- Ability to manage multiple priorities in a fast-paced, matrixed environment.
- Proficiency in SAP, MasterControl, and Microsoft Office Suite.
- A self-starter with a collaborative mindset and a passion for continuous improvement.
What you'll get in return
Flexible working options available.
What you need to do now
For more information on this or any other Regulatory Affairs contract jobs, please apply for this advert.